The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
A speech restoration technique for persons who have had their larynx (voice box) surgically removed is known wherein air from the trachea is diverted from its normal flow path out through the tracheostoma to a flow path through a voice prosthesis providing a more or less permanent passageway to the esophagus. Esophageal speech results. See U.S. Pat. Nos. 4,435,853; 4,614,516; and 4,911,716. Voice prostheses currently in use for providing controlled air pathways through tracheoesophageal punctures incorporate flexible retention collars. The retention collar lies against the esophageal surface of the tracheoesophageal wall to reduce the likelihood of dislodgement of the prosthesis from the puncture. While this configuration substantially improves retention, the presence of the large retention collar makes insertion of a prosthesis more difficult and traumatic to the tissue surrounding the tracheoesophageal puncture. A possibility inherent in difficult or traumatic prosthesis insertion is incomplete insertion. Incomplete insertion may result in aspiration of the prosthesis into the airway. The prosthesis may be expelled by coughing, requiring endoscopic retrieval from the airway. Additionally, concern about prosthesis insertion difficulty may prevent some patients and physicians from employing this method of voice restoration.
According to an aspect of the invention, a retainer soluble in fluid is provided for atraumatic insertion of a prosthesis into a puncture in the tracheoesophageal wall. The prosthesis includes a cylindrical body and a flexible first flange provided on an outside surface of the cylindrical body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body. The retainer retains the flange in its resiliently folded orientation.
To reduce the traumatic experience, the esophageal flange can be placed within a dissolvable capsule (referred to herein as “gel cap”) to reduce the overall dimensions and facilitate the insertion through the tracheoesophageal puncture. Once in place, saliva or other liquid can be swallowed to dissolve the capsule and allow the esophageal flange to expand to its normal dimension and secure the voice prosthesis within the tracheoesophageal puncture.
In order to confirm proper deployment of the esophageal flange, a technician would typically insert a non-tipped end of a cotton swab or other elongated device into the prosthesis device and press against the valve flap at the distal end of the voice prosthesis. If the valve flap can be visually confirmed internally to open without obstruction, the technician could assume that the gel cap had dissolved and that the esophageal flange of the voice prosthesis had deployed to its proper location. This tactile and internal visual confirmation, unfortunately, is not always possible, for example, due to anatomical location of the voice prosthesis or in a voice prosthesis that has two valves. The clinician could also rotate the prosthesis device within the tracheoesophageal puncture to confirm proper deployment of the esophageal flange.